Vice President / Sr. Vice President, Drug Safety & Pharmacovigilance

FTE Role - Hybrid in Foster City, CA (2-3 days onsite)

W2 Only

POSITION SUMMARY

The VP / SVP, Safety and Pharmacovigilance will oversee all aspects of both clinical and commercial drug safety and safety operations for the company across all compounds.

The optimal candidate participate will lead a safety department and work within a cross-functional team of clinical, regulatory, scientific, biometrics, operational and commercial colleagues and interact with vendors, external experts, investigators and government agencies.

The Head of Safety is expected to strategically lead Mirum’s pharmacovigilance and safety operations, and other activities related to drug safety for all clinical stage and commercially approved compounds, with an ability to build for future compounds.

JOB FUNCTIONS / RESPONSIBILITIES

• The Executive Director / VP, Drug Safety and Pharmacovigilance will be responsible for all medical safety aspects of clinical development and post market surveillance of medicinal products in the client’s portfolio
• Lead both medical safety and safety operations across clinical and commercial compounds
• Oversight of vendor deliverables and measurements associated with safety & PV for clinical programs, as well as approved products
• Strategic oversight and overall responsibility of commercial safety reporting requirements for US, EU and other international territories, as required
• Management, oversight and mentorship of team with strategic and tactical view for future build and planning
• Partner with clinical development representatives to lead safety signal assessments and validate safety signals
• Participate in health authority interactions (both written and verbal) and inspections regarding safety risk management;

may also oversee a team member who assists in such interactions

• Oversight of Drug Safety Committees & Core Safety Information
• Heading the safety strategy for regulatory communication and providing oversight of to support submission activities
• Contribute written summaries and provide safety review for safety components of protocols, IB, clinical study reports, regulatory submissions, label negotiations etc.

by working directly with team members and offering tactical support when needed

• Oversee, Write or Review of periodic aggregate / safety reports
• Oversight of Case Processing and Medical Review of SUSARs and CSR Narrative review, and follow up with site investigators
• Perform Benefit-Risk Assessments in collaboration with Clinical Development, as required
• Ensure compliance with global safety requirements and inspection readiness, including root-cause analyses
• Manage relationships with clients and team members providing expert safety knowledge

QUALIFICATIONS

• Education / Experience : MD or PharmD accompanied by relevant safety & PV experience in biotechnology or pharmaceutical industry, plus 10+ years of industry experience REQUIRED
• Experience in building teams, directly or matrixed and leading projects
• Experience in risk management strategies and signal detection strategies
• Robust knowledge of global PV requirements
• Experience overseeing safety / PV vendors
• Experience with regulatory authority inspections
• Ability to provide robust safety strategies at the highest level as well as perform detailed work to support Phase 1-3 programs, as well as commercial products
• Strong business acumen and ability to collaborate with cross-functional partners to achieve enterprise goals
• Effective written, verbal communication and interpersonal, relationship-building skills
• Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects
• Organized, attention to detail, and able to meet timelines in a fast-paced environment
• Able to work with a high level of autonomy and independence
• Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.

Compensation :

The estimated pay range for this position is USD $375,000 - $400,000 / Yr. and is an Exempt role.

Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and location.